The National Institute for Health and Care Research (NIHR) Patient Recruitment Centre (PRC): Leicester is running a clinical research trial of the first vaccine developed to prevent common infections, such as urinary tract infections (UTI), caused by the bacteria E. coli. The trial is looking for adults aged 60 years and older with a history of UTI in the past two years.
UTI is an infection in the parts of the body such as kidneys or bladder that are involved in urine production. Sometimes for men, E. coli may cause an infection and inflammation of the prostate gland, a walnut-sized gland situated directly below the bladder. This is called prostatitis. Infections caused by E. coli can be invasive, spreading to the bloodstream and other locations in the body. This can be life-threatening and lead to hospitalisation. Although invasive infections affect all ages, adults aged 60 years and older have an increased risk. This risk increases further in older people who have had a UTI in the past.
The phase three trial will test the effectiveness and safety of a new, single injection vaccine which is being developed by Janssen, a research and development healthcare company owned by Johnson & Johnson. In this trial the vaccine will be compared to inactive substance, also known as a placebo.
Participants will be aged 60 years or over and with a history of UTI in the past two years that required antibiotic treatment. It is expected that approximately 18,556 study participants will be recruited worldwide, of which between approximately 2500-3000 are expected to be recruited in the UK. Participants will be in the study for about three years after receiving the study vaccine.
Martin Wiselka, Professor of Infectious Disease at Leicester’s Hospitals and Principal Investigator for the trial, explains: “Some people suffer greatly from repeated urinary tract infections, which can be serious and life-threatening if the infection causes sepsis. Increasingly E. coli strains are developing antibiotic resistance, meaning the infection they cause can’t be treated by the antibiotic medicines usually prescribed by doctors. There are no vaccines routinely used in the UK for prevention of recurrent UTIs or to help the immune system respond to bacteria which cause UTIs. Finding a vaccine could prevent people, most often over the age of 60, from becoming very ill and reduce hospital admissions.”
Professor Melanie Davies, Clinical Director of NIHR Patient Recruitment Centre: Leicester says: “We are pleased to bring this important research to our local population in Leicester, Leicestershire and Rutland through our dedicated Patient Recruitment Centre: Leicester. We will be working with the wider healthcare system to ensure we reach those who could really benefit from taking part in this trial.
“We hope that through our Patient Recruitment Centre we will continue to provide local people with opportunities to take part in health research.”
The PRC is one of five in England, dedicated to setting up and delivering late phase commercial clinical trials in the NHS at pace and scale. PRC Leicester is hosted by the University Hospitals of Leicester NHS Trust and based at Leicester General Hospital.
If you are interested in the possibility of taking part in this research trial, please contact the study team by emailing email@example.com. To find out more about the Patient Recruitment Centre: Leicester, visit our website: https://local.nihr.ac.uk/prc/leicester/
For media enquiries and interview requests, please contact:
Rachael Dowling, Head of Research Communications
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